What is the recommended dose of ferric carboxymaltose (intravenous iron) for treating heart failure with anemia?

Ferric Carboxymaltose Dosing in Heart Failure with Anemia

For patients with heart failure and anemia, the recommended dose of ferric carboxymaltose is 1,000 mg on day 1 followed by 500-1,000 mg at week 6 (based on weight), with maintenance doses of 500 mg at weeks 12,24, and 36 if iron deficiency persists. 1

Dosing Protocol Based on Weight and Hemoglobin

Initial Dosing

• For patients weighing <70 kg:

  • Hemoglobin <10 g/dL: 1,000 mg on day 1, followed by 500 mg at week 6 1
  • Hemoglobin 10-14 g/dL: 1,000 mg on day 1, no dose at week 6 1
  • Hemoglobin >14 to <15 g/dL: 500 mg on day 1, no dose at week 6 1

• For patients weighing ≥70 kg:

  • Hemoglobin <10 g/dL: 1,000 mg on day 1, followed by 1,000 mg at week 6 1
  • Hemoglobin 10-14 g/dL: 1,000 mg on day 1, followed by 500 mg at week 6 1
  • Hemoglobin >14 to <15 g/dL: 500 mg on day 1, no dose at week 6 1

Maintenance Dosing

• Administer 500 mg at weeks 12,24, and 36 if serum ferritin <100 ng/mL or serum ferritin 100-300 ng/mL with transferrin saturation <20% 1, 2

Administration Method

• Ferric carboxymaltose can be administered as:
  • Undiluted slow intravenous push at approximately 100 mg/min (15 minutes for 1,000 mg dose) 1
  • Intravenous infusion diluted in sterile 0.9% sodium chloride (maximum 250 mL for 1,000 mg) administered over at least 15 minutes 1, 2
• Concentration should not be less than 2 mg iron/mL to maintain stability 1

Diagnostic Criteria for Iron Deficiency in Heart Failure

• Iron deficiency is diagnosed when:
  • Serum ferritin <100 μg/L, or
  • Serum ferritin 100-299 μg/L with transferrin saturation <20% 2

Clinical Evidence Supporting IV Iron in Heart Failure

• Intravenous ferric carboxymaltose significantly improves:
  • Exercise capacity (6-minute walk test distance) 2
  • NYHA functional class 2, 3
  • Quality of life measures 2, 3
  • Patient Global Assessment scores 2
  • Potential reduction in heart failure hospitalizations 2

Monitoring and Follow-up

• Re-evaluate iron status 3 months after initial treatment 2
• Avoid early re-evaluation (within 4 weeks) as ferritin levels are markedly elevated immediately following IV iron administration 2
• Consider evaluating iron status 1-2 times per year in patients with chronic heart failure 2
• Monitor serum phosphate levels in patients requiring repeat courses, especially if within 3 months of previous treatment 1

Important Considerations and Cautions

• Oral iron therapy has been shown ineffective in heart failure patients with iron deficiency (IRONOUT HF trial) 2
• Contraindications include:
  • Hypersensitivity to ferric carboxymaltose or its excipients 2
  • Known serious hypersensitivity to other parenteral iron products 2
  • Anemia not attributed to iron deficiency 2
  • Evidence of iron overload 2
• Use with caution in patients with:
  • Acute or chronic infection (stop treatment in patients with bacteremia) 2
  • Known drug allergies, especially those with history of severe asthma, eczema, or atopic allergies 2
  • Immune or inflammatory conditions 2

Regional Differences in Dosing

• In the USA, the usual dose for ferric carboxymaltose is two individual doses of 750 mg each 2
• In Europe, 1,000 mg is routinely administered per dose 2
• The FDA-approved dosing for heart failure specifically follows the weight and hemoglobin-based protocol outlined above 1